Status:
TERMINATED
Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how we...
Detailed Description
OBJECTIVES: Primary * To determine the effect of sunitinib malate on occult tumor cells (OTC) in the bone marrow of patients with high-risk stage I-III breast cancer. Secondary * To evaluate the n...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed high-risk breast cancer
- Stage I-III disease
- Has undergone definitive surgery with or without radiotherapy
- Completely resected disease
- Bone marrow aspirate positive for occult tumor cells, defined as ≥ 10 occult tumor cells/mL by IHC and flow cytometry
- If the patient received either no adjuvant therapy or hormonal therapy alone, the aspiration may have been performed at diagnosis as part of the large micrometastasis study at UCSF, or following diagnosis if the patient underwent initial surgery elsewhere (or underwent surgery following neoadjuvant therapy for breast cancer)
- If the patient received adjuvant chemotherapy, the aspiration must have been performed ≥ 3 weeks after completion of chemotherapy
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- WBC count normal (3.4-10 x 10\^9/L)
- Hemoglobin \> 9.0 g/dL
- Platelet count normal (140-450 x 10\^9/L)
- ANC normal (1.8-6.8 x 10\^9/L)
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN
- TSH and T4 levels normal
- LVEF \> 50%
- Systolic BP \< 140 mm Hg and diastolic BP \< 90 mm Hg
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of HIV infection
- No concurrent severe illness that would likely preclude study compliance
- No other malignancy within the past 5 years except basal cell carcinoma of the skin
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior sunitinib malate
- Prior adjuvant chemotherapy, including trastuzumab (Herceptin®), allowed provided it was completed within the past 6 months
- Prior surgery following neoadjuvant chemotherapy or hormonal therapy allowed
- No concurrent potent CYP3A4 inducers
- No concurrent trastuzumab
- Concurrent hormonal therapy or radiotherapy allowed
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00824538
Start Date
February 1 2009
End Date
December 1 2013
Last Update
April 5 2018
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